Such safety needle devices are used for the application of medicaments, for example in the field of oncology. In the context of a therapy medicaments have to be applied frequently and over a longer period of time. To achieve this painless and with minimal tissue damage for example, a port is attached to a port catheter subcutaneously on the chest of the patient. A tube of the port catheter connects the port with the vein close to the heart in order to bring the medicament quickly into the bloodstream. In this case the port catheter has a chamber which is closed by a silicon membrane. The safety needle device is pierced through the tissue of the human or animal body and the membrane until the needle tip of the safety needle device reaches the bottom of the port. The opening of the needle tip is now located in the hollow chamber of the port and the medicament can be directed into the patient's body. In order to prevent a usually pain causing movement of the needle, the needle housing is attached to the skin with a patch. Upon removal of the needle, the port has to be kept down, since it is otherwise lifted due to the friction between the needle and the membrane which causes pain due to the connection with the tissue of the human or animal body. The risk of injury is very high after the removal of the safety needle device. To reduce needlestick injuries and associated risks of infection, at least the sharp needle tip should be securely covered against contact. The manual placing of the cover used for transportation is not suitable to protect the medical personnel which removes the needle from the port against injuries, in particular because a risk for injury exists when manually placing the cover used for transportation.
EP 1 562 659 B1 discloses a safety needle device, in particular for puncturing of a subcutaneously implanted port in a human or animal body. The device comprises a base plate, a needle carrier plate and a cover plate, wherein the base plate and the needle carrier plate are each hingedly connected to the cover plate. An angled needle is provided for the needle carrier plate, which has a distal, perforated leg and a proximal leg for the injection of a medicament. The base plate comprises a through-hole, through which the proximal leg of the needle can be passed. Furthermore, the cover plate also has a through-hole for the distal leg of the needle. In the first state the distal leg of the needle is passed through the through-hole in the base plate and through the through-hole in the cover plate. In this state the base plate and the needle carrier plate form an upper part of the device whereas the cover plate forms a lower part of the device, wherein the upper part and the lower part are located on each other. In this state the distal leg of a needle protrudes downwardly from the device and can be inserted into the subcutaneously implanted port. For this purpose the upper part of the device comprises two wings which can be folded into a vertical position in order to better insert the device into the port. During the use of the disclosed safety needle device the device is being fixed on the surface of the human or animal body by means of plaster. For removal of the safety needle device, the lower cover plate also comprises two wings, with which the cover plate can be fixed simultaneously with the port relatively to the human or animal body during removal of the safety needle device. To pull out the distal leg of the needle from a port, the wings at the upper part of the device are positioned vertically and the operator can move the upper part to the top with the other hand while the lower part is fixed relative to the human or animal body. Once the distal leg of the needle has been pulled out of the human or animal body and the needle tip exits the trough-hole in the cover plate, thereby the distal leg moves, caused by a pretention to a pincushion provided at the cover plate, protecting the needle tip from contact. Due to the pretension an undesirable lateral movement of the needle tip may be caused, before the distal leg of the needle has left the port catheter or the human or animal body, respectively.
WO 03/074112 A1 discloses a Huber needle-assembly with a safety mechanism. This device comprises a housing with a curved through-hole for a feed line. At the end of the curved through-hole the needle is arranged for the puncture of a human or animal body in a subcutaneously implanted port. Further a protective cover is arranged within the curved through-hole which pushes a lever over the needle to protect it from contact after the actuation. Prior to the removal of the device from the port the lever is operated and during removal of the needle of the port the protective cover automatically slides over the needle so that the operating personnel cannot injure themselves on the needle tip. A disadvantage of this device is the high structural shape which is particularly uncomfortable for long term applications of several hours or days for the patient.
EP 2 016 964 A1 discloses a safety needle device with a cover plate and a housing. The device further comprises a curved needle, whose distal end emerges from a through-hole and a cover plate in the first state and whose proximal end is arranged within the first housing in the first state. The cover plate and the housing of the device are arranged adjacent to each other in the first state. Furthermore, the device comprises a protective cover which is attached to the cover plate in the region of the through-hole of the distal end of the needle and extends into the housing while surrounding the curved needle shaft. When removing the distal end of the needle from a port, the housing is moved vertically from the cover plate. At the same time, the entire needle shaft is surrounded by the protective cover, whose end moves within a housing. Once the needle has been completely removed from the port, the needles tip is moved in such a way that it cannot inadvertently come out again through the trough-hole of the cover plate. A disadvantage of this device is that the removal of the needle from the port depends only on the skill of the operator and can cause pain for the patient when pulling out the needle in an angular direction.
EP 1 256 355 B1 discloses a safety guard adapted for the use with a needle device, comprising a main body, a pair of butterfly wings extending from the main body to the outside and a needle, which preferably extends at an angle perpendicularly from one end of the main body and further comprising an elongated substantially hollow shield, whereas said shield has open ends and an elongated slot extending between the open ends; a string which is connected with the device, so that slot and needle are substantially parallel to each other, and a fixing means which is adapted to arrange the shield in a first position substantially in parallel to the main body and to enable the shield to be rotated by a spring force to a second position e to surround and/or enclose the needle.
FR 2941867 describes a safety needle device, in particular for puncturing of a in a human or animal body subcutaneously implanted port comprising a cover plate, a needle and a housing. The cover plate has a through-hole for the needle which is attached to the housing. A collapsible sleeve is arranged between the housing and the cover plate. In a first state the needle tip protrudes through the through-hole in the cover plate and can be inserted into the port. In this state the sleeve between the cover plate and the housing is arranged folded up. When removing the needle from the port, the cover plate is fixed relatively to the human or animal body and the housing is removed from the cover plate, whereby simultaneously deploying the sleeve. In a second state the needle is completely removed from the port and is arranged between the cover plate and the housing within the deployed sleeve in a protected way. In order to prevent a needle tip from exiting the trough-hole of the cover plate again the needle tip moves to a pincushion arranged on the cover plate after removal from the port. Due to the pretension of the needle for a movement on the pincushion and the free movement between cover plate and the housing during removal of the needle, it is not guaranteed that the needle is pulled out perpendicularly to the surface of the human or animal body from the port, which leads to the previously mentioned disadvantages.
U.S. Pat. No. 7,097,367 B2 discloses a safety needle device, in particular for puncturing a subcutaneously implanted port in a human or animal body. The device comprises a cover plate, a needle, a two-part foldable housing and guiding means, which are arranged between the cover plate and the housing. In a first state the needle tip extends through a through-hole in the cover plate downwards out of the device and can be inserted into a subcutaneously implanted port. In this state the housing has an elongated shape. When the needle is removed from the port, the two-part housing is pushed together by the guiding means. An advantage of this embodiment is that the movement of the needle is guided relative to the port and human or animal body. A disadvantage of this embodiment is the very complex structure of the housing and the guiding means between the cover plate and the housing.
WO 2007/137339 A1 discloses another embodiment of the safety needle device in particular for the puncture of a in a human or animal body subcutaneously implanted port. The device comprises a cover plate with a through-hole for a needle which is insertable into the port. The device further comprises to wings which are each formed in two parts and wherein one part is guided movably in relation to another part. In a first state of the device the wings are each folded onto the cover plate and are arranged substantially in parallel to the surface of the human or animal body, and the needle extends through the through-hole in the cover plate out downwards and is insertable into a port. For removal of the needle from the port the wings are at first folded together vertically and are arranged adjacent to each other. Subsequently the relatively movable parts of the wings are removed from the surface of the human or animal body in a right angle, causing the needle to be removed from the port. After the removal, the needle is arranged in a cavity between the two wings and protected against contact. A disadvantage of this device is the complex structure, in particular the two-part wing and the guiding of the wing parts to each other.
EP 1 011 759 B1 discloses a safety apparatus for sheathing a medical needle, comprising a hollow bore cannula securely affixed in a hub and having at least one sharpened tip to form the medical needle; a molded part hingeably joined to said hub, the moulded part comprising an elongated sheath which comprises a plurality of serially interconnected substantially rigid segments each of which is interconnected to at least one adjacent segment by a hinge, each of the sheath segments comprising an open office orifice through which the cannula passes, and a channel in which the cannula is disposed when the sheath is linearly extended, the sheath and the hinges being disposed to permit folding of the sheath about the hub in a first state to permit usable access to the sharpened tip in a medical procedure and extending of the sheath to a substantially planar disposition along the cannula in which the cannula is disposed along the channel, extension of the sheath involving rotation of each sheath segment which has an orifice formed in it for the cannula about an axis which contains the orifice, the sheath including at least one latching member which catches and securely affixes the cannula to the sheath, the sheath and the cannula, in combination, forming a substantially rigid body which protectively encloses said sharpened tip and dies access thereto.
A disadvantage of the device is on the one hand the complex design of the protection device and on the other hand the high construction of the device in the first state. Furthermore, the safety device does not unfold independently, but must be operated by the operator upon removal of the needle from the human or animal body.
WO 02/096493 A1 describes a safety needle device having a first housing, a second housing, a needle and a foldable arranged protective element for the shaft of the needle between the first and the second housing. When the needle is removed from the human or animal body, the first housing is removed from the second housing, thereby unfolding the foldable protective element which then surrounds the shaft of the needle. After the needle has been removed from the human or animal body, the needle tip is arranged within the second housing and protected from contact. A disadvantage of this device is especially the high construction, whereby the device is not suitable for long term applications because the device would be disturbing for the patient.
EP 1 430 921 A1 discloses a safety needle device, in particular for puncturing of a in a human or animal body subcutaneously implanted port comprising a first housing and a second housing, a needle and a flexible sleeve arranged between the first and the second housing. In a first state the first housing and the second housing are arranged adjacent to each other and are fixed relatively to each other. In this state the needle tip protrudes from the second housing and can be inserted into a port. The protective sleeve is disposed within a cavity in the first housing. To remove the needle from the port, the locking between a first housing and the second housing is released and the second housing is fixed by the operator relatively to the human or animal body, for example by sticking. Subsequently the needle is removed from the human or animal body, which unfolds the protection sleeve arranged between the first housing and the second housing. In a second state the needle is completely pulled out of the human or animal body, wherein the needle tip is disposed within the second housing and the shaft of the needle is surrounded by the protection sleeve. The disadvantage of this device is particularly the construction height, so that the device is not suitable for long term use on patients.
US 2008/0262434 A1 discloses another safety needle device, in particular for puncturing of a in a human or animal body subcutaneously implanted port. The safety needle device comprises an upper housing to which a supply line is connectable and in which a hollow needle with a corresponding holder is arranged. The holder for the needle and the hollow needle are aligned perpendicular to the surface of the human or animal body. The device further includes a lower cover element with a through-hole for the hollow needle and a closing device for the through-hole to close the through-hole after the hollow needle has been pulled out of the human or animal body and the through-hole in the cover plate. Between the upper housing and the lower cover plate a conical protection sleeve is arranged, which surrounds the needle after removal from the human or animal body. The conical protection sleeve consists of a resistant plastic film. When removing the hollow needle from the human or animal body, the cover plate is fixed relatively to the human or animal body, for example by sticking. Subsequently the upper housing is moved relatively to the lower cover plate and thus the hollow needle is removed from the human or animal body. The conical protection sleeve has to be stretched for the complete removal of the hollow needle from the human or animal body. This has the advantage that the hollow needle is pushed through the stretched protection sleeve against the lower cover plate and is thus fixed, after the through-hole of the lower cover plate has been closed by the locking means. A disadvantage of the device is that the protection sleeve has to be stretched for removal of the hollow needle from the human or animal body which causes the operator to apply greater forces. Furthermore it is not guaranteed that the needle is pulled out perpendicular to the surface of the human or animal body, during removal of the needle from the human or animal body wherein an angular removal of the needle from the human or animal body can be painful for the patient. Furthermore due to the higher forces that are required to pull out the hollow needle from a human or animal body, the risk exists that the operating personal angularly shifts the upper housing and the connected needle from the puncture axis which is perpendicular to the surface of the human or animal body, and damages the protection sleeve between the upper housing and the lower cover plate.